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Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches


The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.

Because of differences in how national authorities that manage drug pricing and reimbursement view health technology assessment (HTA) tools for biosimilars, there’s an urgent need for agencies to issue clear guidance on when and how to conduct HTAs for biosimilars, according to a recent report.1

global health | Image credit: Tex vector - stock.adobe.com

In some countries, due to confirmed therapeutic comparability, new biosimilars are not systematically evaluated via health technology assessments anymore | Image credit: Tex vector - stock.adobe.com

The systematic literature review was published by the ISPOR Biosimilars Special Interest Group in Value in Health and shines a spotlight on the limited guidance that exists on how to assess biosimilars' value and on appropriate economic evaluation techniques. The study also outlined current HTA approaches used by federal agencies for biosimilar value assessment.

HTA methodologies evaluate new biologics and biosimilars for adoption based on factors like efficacy, safety, and cost-effectiveness. However, assessing biosimilars has posed challenges for HTA agencies due to unique regulatory frameworks.

Although some regulators approve biosimilars based on specific studies and indications, HTA approaches vary. Reimbursement for biosimilars often relies on price comparisons, raising concerns about long-term market sustainability. This study investigated an HTA's role in biosimilar assessment and current agency approaches to value evaluation.

“The role of HTA in informing pricing and reimbursement decisions for new biologics is generally well established,” said author Teresa Barcina Lacosta, PharmD, PhD, chair-elect of the ISPOR Biosimilar Special Interest Group and a data and policy analyst at the European Medicines Agency Labeling Office, in a statement on the report.2 “However, it is less evident how HTAs can inform pricing and reimbursement decisions for biosimilars…. This study reflects on the evolution of the role of HTAs for biosimilars and has aimed to investigate current HTA agency approaches for biosimilar value assessment.”

Semi-structured interviews (n = 16) were conducted with HTA experts from Egypt, Brazil, Canada, Colombia, the US, Malaysia, Australia, Bulgaria, Hungary, Italy, Sweden, and the United Kingdom. The data from the interviews were complemented with literature findings, including full-text publications, conference abstracts and presentations, research posters, and institutional documents published in English, French, Portuguese, Spanish, Hungarian, Bulgarian, and Swedish. Interview participants were identified through ISPOR’s network and HTA institutions’ websites.

Countries with established HTA methods have historically guided biosimilar reimbursement. However, due to confirmed therapeutic comparability, new biosimilars are not systematically assessed via HTAs anymore. In some places like Australia, Québec in Canada, and Sweden, HTAs still inform reimbursement conditions but through streamlined pathways.

England's National Institute for Health and Care Excellence automatically reimburses all biosimilars like the originator. European institutions have updated HTA guidelines, reducing involvement based on specific circumstances, such as reduced involvement in biosimilar value assessment, focusing on specific situations like nonreimbursed originators, differences in indications, and pricing premiums for biosimilars.

In regions outside Europe, Canada, and Australia, the use of HTA methods for assessing biosimilar value has been limited. In the US, HTAs are conducted by various health plans and groups like the Institute for Clinical and Economic Review (ICER), but there's no national program guiding coverage. ICER's assessments influence major payers, yet their focus on biosimilars varies.

Latin America faces challenges in HTA implementation due to health care system structures and data limitations. Countries like Brazil and Colombia involve HTAs in public sector decision-making but with limited biosimilar-specific evaluations. Malaysia uses HTAs for medicines procurement but lacks formal guidelines for biosimilar assessments. Egypt's pricing regulations influence biosimilar pricing, and while HTA processes are developing, biosimilar value assessment is still evolving.

The researchers emphasized the importance of considering various factors in biosimilar assessment. This includes gathering cost and resource data, understanding stakeholder preferences and adherence issues, using real-world data for long-term insights, and updating reimbursement based on emerging information and biosimilar impact. They also noted challenges in data collection, addressing patient preferences, conducting postmarket reviews, and valuing added services. These considerations were highlighted as essential for effective disease management and treatment access.

Lacosta concluded, “In line with these objectives, biosimilar value assessment has been simplified, with an increasingly common practice to rely on price negotiations rather than on HTA methodologies…. However, HTA guidelines have generally been developed for on-patent pharmaceuticals, without considering particularities relating to biosimilars. In this respect, our study has highlighted the need for clearer guidance at the HTA level.”


Lacosta TB, Inotai A, Pereira CL, Barbier L, Simoens S. Mapping health technology assessment agency approaches for biosimilar value assessment: an ISPOR special interest group report. Value Health. 2024;27(5):543-551. doi:10.1016/j.jval.2024.01.018

When and How to Conduct Health Technology Assessments for Biosimilars? News release. ISPOR—The Professional Society for Health Economics and Outcomes Research; May 13, 2024. Accessed May 13, 2024. https://www.newswise.com/articles/when-and-how-to-conduct-health-technology-assessments-for-biosimilars

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